Cell Line Development & Engineering

Monday, May 20, 2013
7:00 Registration and Coffee
8:00 Chairwoman’s Opening Remarks – The Legal, Regulatory
and Technical Landscape
Laurie Donahue-Hjelle, Ph.D., Director, New Product Development,
Life Technologies
Keynote Addresses
8:15 CASE STUDY Coordinated Oscillations in Cortical
Actin and Ca(2+) Correlate with Cycles of
Vesicle Secretion
The actin cortex both facilitates and hinders the exocytosis
of secretory granules. How cells consolidate these two
opposing roles was not well understood. Here we show using multi-color
fluorescent microscopy that antigen activation of mast cells induces
oscillations in Ca(2+) and PtdIns(4,5)P(2) lipid levels that in turn drive
cyclic recruitment of N-WASP and cortical actin level oscillations. These
oscillations increase secretion efficiency, explaining how the actin cortex can
function as a carrier as well as barrier for vesicle secretion.
Roy Wollman, Ph.D., Assistant Professor, Chemistry and Biochemistry,
University of California San Diego
8:45 CASE STUDY • UNPUBLISHED DATA Higher-Faster-Further:
Why It Makes Sense to Invest in Innovation to
Achieve Disruptive Improvements – A Case
Study About 2nd Generation Media Development
The pressure to reduce COGS will likely increase. The
biopharmaceutical industry needs to pro-actively address this development
by having the appropriate strategies to increase productivity significantly. This
requires a dedicated commitment to innovative ideas that include state of the art
scientific approaches for significant improvements. The case study correlates the
investment in innovation with the outcome of a multi-year innovation project.
Torsten W. Schulz, Ph.D., Director, Cell Culture,
Boehringer Ingelheim Fremont, Inc.
9:15 Speed Networking Refreshment Break and Poster/Exhibit Viewing
Working Closer with Drug Discovery and Research to
Improve Cell Line Development and Minimize Risk
10:15 UNPUBLISHED DATA Cell Line Development for Novel
Molecules - Perspectives from the Interface of
Discovery and Development
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/CellLine for updates.
Stephanie E. Rieder, Senior Scientist III, Global Biologics, AbbVie
10:45 CASE STUDY • UNPUBLISHED DATA Molecular Assessment (MA)
Programs – Balancing Upstream Work with
Downstream Payoffs
Producing recombinant proteins and antibodies with manufacturability
problems often presents a significant barrier to the clinical and commercial
feasibility of a project. Methods to identify problematic molecules early in the
drug development process can serve a valuable purpose by either eliminating
these molecules from consideration or by providing advance notice so that
proactive steps can be taken to minimize timeline delays. This presentation
describes selected Molecule Assessment (MA) considerations implemented at
Genentech, highlighting examples identified at different stages in the process.
Laura Simmons, Senior Scientist, Early Stage Cell Culture, Genentech, Inc.
“Quite worthwhile!
Informative, encompassing, broad and yet relevant topics.
Great venue for discussion and interaction.”
- Lynn Davis, Ph.D., Senior Research Biologist, Bend Research Inc.
11:15 CASE STUDY • UNPUBLISHED DATA Surviving the Valley of Death - Pre-
Cell Line Generation Strategies to Reduce Attrition in Later
Stages of Biopharmaceutical Development
The majority of new biopharmaceutical candidates fail during preclinical
and clinical development in what some describe as the ‘valley of death’
of drug development. The challenge faced by drug developers is to find
new ways of screening out early on in development those compounds
that have a lower probability of success. Developability strategies applied
before the development of production cell lines do address aspects
of manufacturability, safety and delivery that could impact negatively
later stages of development. They constitute an alternative approach to
QbD, targeting risks present in the product itself. It is expected that the
incorporation of this type of assessment early on in biopharmaceutical
development will help reduce cost, attrition and development timelines.
Jesús Zurdo, Ph.D., Head of Innovation, Biopharmaceutical Development,
Lonza, United Kingdom
11:45 Technology Workshop
Simple Methods to Make Your Cell Line Shine
Tremendous efforts have gone into shortening stable cell line development.
Once those months are invested, there is a desire for the selected clone to
shine very quickly with regards to titer and sustainable product quality. This
presentation will explore simple methods to attain next level titers in CHO
fed-batch processes once you’ve selected your expression clone.
Cynthia Hoy, Ph.D, Process Science Fellow, PD Direct® Services –
Life Technologies
12:15 Luncheon and Poster/Exhibit Viewing
1:15 Chairman’s Remarks - Are ‘omics Approaches Anything
other than Intellectual (Academic) Interest - Does Data
Obtained have Track Record of Translating to Making a
Difference in Processes
Kevin McCarthy, Ph.D., Group Leader for Cell Sciences, EMD Serono Inc.
Application, Integration and Characterization of ‘Omics
in Cell Line Development
1:30 UNPUBLISHED DATA Application of Genomic Technologies
to Cell Line Development
The recent publication of a draft CHO genome has set the stage for detailed
molecular and genetic understanding of growth and protein production in
mammalian cells, which will enable - the recognition of patterns of gene expression
that correlate to process suitability and allow knowledge based selection of clones;
development of pathway engineering strategies to improve the host cell line;
process, media and feed development by optimisation of cellular responses.
Nicole Borth, Ph.D., Professor, Department of Biotechnology,
University of Bodenkultur, Austria
2:00 UNPUBLISHED DATA Development of a CHO
Mass Spectrometry Database
New sequence information on Chinese hamster ovary cells offers the potential
to improve the interpretation of CHO proteomic results, and thus a greater
understanding of the underlying biological mechanisms of CHO cells in
biopharmaceutical processes. In this presentation, we demonstrate the use
of CHO-specific sequence information to improve the identification of CHO
proteins using mass spectrometry-based proteomic analysis.
Paula Meleady, Ph.D., Senior Research Scientist, Program Leader,
Proteomics Core Facility, National Institute for Cellular Biotechnology,
Dublin City University, Ireland
2:30 UNPUBLISHED DATA Engineering the CHO Genome for Improved
Transgene Integration and Expression
Epigenetic regulatory DNA elements prevent silencing and increase transgene
integration and transcription for high and stable therapeutic production.
We have sequenced the genome and transcriptome of a CHO cell line and of
derived producer cell clones, yielding information on the integration locus,
transgene integrity and copy number. Information on possible mechanisms
allowing vector genomic integration was also obtained, providing approaches
to further optimize transgene integration and expression.
Nicolas Mermod, Ph.D., Professor, Director, Institute of Biotechnology,
University of Lausanne, Switzerland
For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/CellLine 3